�Indevus
Pharmaceuticals, Inc. (Nasdaq: IDEV) proclaimed the mop up of
registration in Protocol MDP 301, a Phase III clinical trial of PRO 2000, the
Company's candidate vaginal microbicide for the prevention of HIV and other
sexually transmissible infections. The trial is sponsored by the United
Kingdom's Medical Research Council (MRC) and conducted by the Microbicides
Development Programme (MDP), an international partnership of researchers
established to develop microbicides for the prevention of HIV contagion.
This trial enrolled 9,395 women at clinics in South Africa, Tanzania,
Uganda, and Zambia. Results from this trial ar expected to be uncommitted by
the end of 2009.
This is the second heavy trial testing the safety and strength of
the 0.5% dose of PRO 2000 and the largest test of whatever microbicide to date.
In July 2007, enrollment of 3,century women was completed in Protocol HPTN 035
sponsored by the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health (NIH). Results from the
HPTN 035 visitation are expected to be available by early 2009.
"The completion of enrolment in this trial simon Marks a significant
milestone for Indevus, our shareholders and for women who may benefit from
a product that provides a female-controlled option for HIV and STD
bar," said Glenn L. Cooper, M.D., chair and headman executive
officer of Indevus. "We take now completed enrollment in two pivotal trials
with over 12,000 women participating. If the trials are successful, we
expect to be in a position to file marketing applications with regulatory
regime, including a New Drug Application with the U.S. Food and Drug
Administration, in 2010."
MDP 301 is a multi-national, randomized, double-blind,
placebo-controlled Phase III trial designed to examine the safety and
effectiveness of PRO 2000 in preventing HIV infection in women. The trial
will also tax effects on other sexually transmitted infections including
herpes virus, chlamydia and gonorrhea. All participants receive condoms and
risk-reduction counsel. The trial opened in October 2005, and is
currently underway at clinical centers in South Africa, Tanzania, Uganda
and Zambia. Completion of the trial is expected in the summer of 2009.
HPTN 035 is a transnational, randomized, placebo-controlled trial
designed to study the safety and effectivity of PRO 2000 and another
nominee vaginal microbicide in preventing HIV infection in women. This
run will besides assess personal effects on early sexually transmitted infections
including herpes, chlamydia and clap. The 0.5% dose of PRO 2000 is
being well-tried in comparison with a placebo and no treatment. All
participants receive condoms and risk-reduction counseling. The trial
involves seven clinical centers in South Africa, Malawi, Zimbabwe, Zambia,
and the United States. The trial opened in February 2005, and 3,hundred healthy
women were enrolled before aforethought recruitment complete in July 2007.
Completion of the HPTN 035 trial is expected later this year. Results from
the trial are expected by early 2009.
About Indevus
Indevus Pharmaceuticals, Inc. is a metier pharmaceutical company
engaged in the learning, development and commercialization of products
to treat atmospheric condition in urogenital medicine and endocrinology. The Company's approved
products include SANCTURA(R) and SANCTURA XR(TM) for overactive bladder,
VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central
precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The
Indevus development pipeline contains multiple compounds within the
Company's core therapeutic areas in addition to several partnered or
partnerable programs. The most advanced compounds in exploitation include,
VALSTAR(TM) for bladder cancer, NEBIDO(R) for male person hypogonadism, PRO 2000
for the prevention of infection by HIV and other sexually-transmitted
pathogens, and the octreotide imbed for acromegaly.
About MDP
The Microbicides Development Programme (MDP) is an Afro-European
partnership to develop vaginal microbicides for the prevention of HIV
transmission. MDP is coordinated jointly by Imperial College, London, and
the Clinical Trials Unit of the UK Medical Research Council. Partner
institutions in Africa ar University Teaching Hospital, Lusaka, Zambia;
Medical Research Council Uganda Virus Research Institute, Entebbe; African
Medical and Research Foundation and National Institute for Medical
Research, Mwanza, Tanzania; the Africa Centre for Health and Population
Studies, KwaZulu Natal, South Africa; South African Medical Research
Council, Durban; and the Reproductive Health and HIV Research Unit,
Department of Obstetrics and Gynaecology, University of Witwatersrand,
Johannesburg, South Africa. In Mozambique, there are two new MDP sites at
the rural Manhica Health Research Centre and at Mavalane Hospital in the
urban capital of Maputo. European partners include the London School of
Hygiene and Tropical Medicine, St. George's Hospital, London, and the
Universities of York, Southampton and Barcelona. Clinical sites ar located
in South Africa, Tanzania, Uganda, Zambia and Mozambique.
MDP has reinforced a vigorous multicultural and multidisciplinary research
network ready to undertake future work of like importance and
complexity. Years of working collegially have built coherency,
efficiency and mutual trust among the scientists, clinical staff, information
managers, and other professionals and support staff comprising this
Afro-European and pan-African clinical test network, as well as sound
relationships with surrounding communities. MDP has likewise achieved
significant improvements in African laboratory capacity and other research
infrastructure, as well as upgrading and reinforcement of professional
capacity at its African research sites.
About PRO 2000
PRO 2000 (naphthalene sulfonate polymer) is a topical vaginal
microbicide under development to prevent the intimate transmission of HIV and
other sexually transmitted diseases.
Forward Looking Statements
Except for the descriptions of historical facts contained herein, this
press acquittance contains advanced statements that involve risks and
uncertainties that could cause the Company's actual results and financial
precondition to dissent materially from those awaited by the
forward-looking statements. These risks and uncertainties are go down forth in
the Company's filings under the Securities Act of 1933 and the Securities
Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, merely
are not limited to: dependence on the success of SANCTURA, SANCTURA XR,
NEBIDO, VANTAS and SUPPRELIN LA; indigence for additional funds and corporate
partners, including for the development of our products; potency of
our sales force; competition and its effect on pricing, spending,
third party relationships and revenues; dependence on third gear parties for
supplies, peculiarly for histrelin, manufacturing, marketing, and
clinical trials; risks ated with being a manufacturer of some of our
products; risks associated with contractual agreements, especially for
the manufacture and co-promotion of SANCTURA and SANCTURA XR and the
manufacture of NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR; reliance on
intellectual dimension and having limited patents and proprietorship rights;
dependency on market exclusivity, changes in reimbursement policies and/or
rates for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL and any
future products; espousal by the healthcare residential district of our approved
products and mathematical product candidates; uncertainties relating to clinical trials,
regulatory approval and commercialization of our products, specially
SANCTURA XR, NEBIDO, and VALSTAR; ware liability and insurance
uncertainties; risks relating to the Redux-related litigation; history of
operating losings and expectation of succeeding losses; uncertainties relating
to controls over financial reporting; valuation of our Common Stock; risks
related to repayment of debts; risks related to increased leverage; general
worldwide economic conditions and related uncertainties; and other risks.
Indevus undertakes no obligation to publicly update any forward-looking
statement, whether as a consequence of young information, future events or
otherwise.
Indevus Pharmaceuticals, Inc.
http://www.indevus.com
View drug information on Sanctura; Supprelin LA; Valstar.
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